Using imatinib to improve outcomes in gastrointestinal stromal tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial focuses on patients diagnosed with gastrointestinal stromal tumors (GIST) and aims to enhance their quality of life through therapeutic drug monitoring of imatinib. By assessing free drug levels and pharmacokinetics, the study seeks to ensure that patients maintain therapeutic levels of imatinib while minimizing side effects. Participants will be monitored for their response to treatment and any improvements in symptoms associated with GIST. The study is designed for patients who have recently started imatinib or are about to begin treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically or cytologically confirmed GIST with KIT mutation or PDGFRA mutation (non-D842V)
* Currently receiving imatinib initiated within the last 3 months or to be started in the next 1 month
* Prior systemic chemotherapy for other malignancy is allowed as long as it was completed within the past 6 months and there is no evidence of disease
* Age ≥18 years
* ECOG performance status of 0 or 1
* Normal organ function

Exclusion Criteria:

* Presence of PDGFRA D842V mutation
* Known allergy to imatinib or allergic reactions to compounds of similar chemical or biologic composition to the study drug
* Concomitant anticoagulation with oral warfarin.
* Use of strong inhibitors or inducers of CYP3A or CYP3A4, drugs metabolized by CYP3A4 or CYP2D6
* Uncontrolled intercurrent illness
* Concurrent malignancy

Where it's running

• Markey Cancer Center
  Lexington, Kentucky, United States Recruiting

Study contacts

• Principal investigator: Reema Patel, MD — University of Kentucky
• Study coordinator: Yvonne A Taul, RN
• Email: Yvonne.Taul@uky.edu
• Phone: 859-323-2354

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Imatinib plus fampridine before surgery for KIT exon 11 gastrointestinal stromal tumor

  This trial tests whether adding fampridine to standard imatinib before surgery is safe and helps shrink KIT exon 11 mutant GIST tumors in adults.

  Recruiting Phase 1 University of California, San Diego · La Jolla, California · NCT07171203

• Oral Liporaxel (paclitaxel) treatment for gastrointestinal stromal tumors

  This study will test whether taking oral Liporaxel (a form of paclitaxel) can help people with advanced GIST who stopped responding to imatinib, sunitinib, and regorafenib and whose tumors have low P‑glycoprotein levels.

  Recruiting Phase 2 Asan Medical Center · Seoul, Songpagu · NCT06326346

• Combination of rivoceranib and paclitaxel for advanced gastrointestinal stromal tumors

  This study is testing if a new combination of two drugs, rivoceranib and paclitaxel, can help adults with advanced gastrointestinal stromal tumors that haven't improved with standard treatments.

  Recruiting Phase 2 Asan Medical Center · Seoul, Seoul · NCT05905887

• 5 years of imatinib treatment for high-risk gastrointestinal stromal tumors

  This study is testing if taking imatinib for five years after surgery can help people with high-risk gastrointestinal stromal tumors avoid their cancer coming back.

  Recruiting Phase 2 Asan Medical Center · Seoul, Seoul · NCT05385549

• Velzatinib for advanced GIST after multiple prior TKIs

  This study tests velzatinib to see if it can shrink or slow tumors in people with metastatic or unresectable GIST who have progressed on or could not tolerate standard therapies.

  Recruiting at 3 sites Phase 2 GlaxoSmithKline · Fukuoka and 2 other locations · NCT07689201

• DCC-2618 in GIST after at least 3 prior treatments

  This trial tests whether DCC-2618 is safe in people with advanced GIST who have already tried at least three other treatments.

  Recruiting at 2 sites Phase 1 Ono Pharmaceutical Co., Ltd. · Kashiwa, Chiba and 1 other locations · NCT07618377

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.